Z-1148-2021 Class II Terminated
FDA device recall Z-1148-2021 was initiated by Northgate Technologies, Inc. on January 15, 2021 and is designated Class II. Reason for recall: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. The recall status is terminated (terminated October 31, 2022). Affected quantity: 45 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 15, 2021
- Termination Date
- October 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 units
Product Description
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
Reason for Recall
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Distribution Pattern
US Nationwide distribution in the states of FL and OH.
Code Information
Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK